Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity | DelveInsight
The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes.
New York, USA, July 22, 2025 (GLOBE NEWSWIRE) -- Melanoma Market Anticipates a Dynamic Shift During the Forecast Period (2025–2034) Owing to the Strong Pipeline Activity | DelveInsight
The melanoma market is predicted to surge during the forecast period (2025–2034) owing to factors, as the increasing incidence of melanoma, the launch of emerging therapies such as Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), and others, heightened UV exposure, advancements in diagnostic techniques, and lifestyle changes.
DelveInsight’s Melanoma Market Insights report includes a comprehensive understanding of current treatment practices, emerging melanoma drugs, market share of individual therapies, and current and forecasted Melanoma market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Key Takeaways from the Melanoma Market Report
- According to DelveInsight’s analysis, the total melanoma market size is expected to grow positively by 2034.
- The United States accounts for the largest market size of melanoma, in comparison to EU4 (Germany, Italy, France, and Spain) and the UK, and Japan.
- In 2024, the total number of incident cases of melanoma was approximately 105K in the US. The trend indicates that melanoma occurs more frequently in males than in females, and around 20% of cases eventually progress to advanced stages (stage III/IV), involving unresectable or distant metastatic disease.
- Prominent companies, including Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others, are actively working on innovative melanoma drugs.
- Some of the key melanoma therapies in the pipeline include Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others. These novel melanoma therapies are anticipated to enter the melanoma market in the forecast period and are expected to change the market.
- In May 2025, Immatics announced the presentation of expanded data from the ongoing Phase Ib clinical trial evaluating IMA203 in heavily pretreated patients with metastatic melanoma
- In April 2025, IDEAYA Biosciences announced a successful FDA Type D meeting on the Phase III registrational trial design that would assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma.
Discover which melanoma medications are expected to grab the market share @ Melanoma Market Report
Melanoma Overview
Melanoma is a type of skin cancer that originates in melanocytes, the pigment-producing cells responsible for giving skin its color. While it is less common than other skin cancers, melanoma is significantly more aggressive and has a higher risk of spreading to other parts of the body if not detected early. It can occur anywhere on the body but is most frequently found on areas exposed to the sun, such as the back, legs, arms, and face.
The primary cause of melanoma is ultraviolet radiation from sunlight or artificial sources like tanning beds, which can damage the DNA in skin cells. Individuals with fair skin, a history of sunburns, a large number of moles, or a family history of melanoma are at higher risk. Genetic mutations, such as in the BRAF gene, also play a significant role in the development of melanoma in certain cases.
Symptoms of melanoma often begin with changes in the appearance of a mole or pigmented area. Warning signs include asymmetry, irregular borders, color variation, a diameter larger than 6 mm, and evolving shape or size, summarized by the ABCDE rule. Itching, bleeding, or the appearance of a new mole can also be concerning signs.
Diagnosis typically involves a thorough skin examination followed by a biopsy of any suspicious lesion. If melanoma is confirmed, further tests such as sentinel lymph node biopsy, imaging scans (CT, MRI, or PET), and blood work may be conducted to determine the stage and whether the cancer has spread. Early diagnosis is critical, as it significantly improves the prognosis and expands treatment options.
Melanoma Epidemiology Segmentation
The melanoma epidemiology section provides insights into the historical and current melanoma patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.
The melanoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
- Total Incident Cases of Melanoma
- Stage-specific Incident Cases of Melanoma
- Mutation-specific Incident Cases of Melanoma
- Line-wise Treated Cases of Melanoma
Download the report to understand which factors are driving melanoma epidemiology trends @ Melanoma Treatment Algorithm
Melanoma Treatment Market
There remains a substantial unmet need for effective treatment options in melanoma patients who are resistant to, unsuitable for, or unresponsive to standard therapies like checkpoint inhibitors or BRAF/MEK-targeted treatments.
The FDA has approved several therapies for melanoma, including AMTAGVI (lifileucel, Iovance Biotherapeutics), OPDUALAG (nivolumab + relatlimab, Bristol Myers Squibb), KEYTRUDA (pembrolizumab, Merck), OPDIVO (nivolumab, BMS), KIMMTRAK (tebentafusp-tebn, Immunocore), YERVOY (ipilimumab, BMS), TECENTRIQ (atezolizumab, Roche), among others.
AMTAGVI, from Iovance Biotherapeutics, became the first FDA-approved, personalized, one-time T cell therapy in February 2024. It is intended for adults with unresectable or metastatic melanoma who have previously been treated with PD-1 inhibitors, and for those with BRAF V600 mutations, after BRAF inhibitor ± MEK inhibitor therapy. That same year, Iovance submitted a Marketing Authorization Application (MAA) for lifileucel to the EMA in June (validated in August) and to the UK’s MHRA in October.
In June 2025, Iovance announced that the final results from the Phase II C-144-01 trial of AMTAGVI in advanced melanoma patients were published in the Journal of Clinical Oncology and presented at the 2025 ASCO Annual Meeting.
Bristol Myers Squibb’s OPDUALAG combines nivolumab, a PD-1 inhibitor, with relatlimab, a LAG-3 inhibitor, and is indicated for the treatment of unresectable or metastatic melanoma. The FDA approved it in March 2022 for adults and children aged 12 and above. However, in February 2025, BMS reported that the Phase III RELATIVITY-098 trial did not achieve its primary endpoint of recurrence-free survival (RFS) in the adjuvant setting for completely resected stage III–IV melanoma, although the safety profile remained consistent with existing data on the combination.
KEYTRUDA and OPDIVO both demonstrate strong efficacy in treating melanoma, though OPDIVO has gained greater commercial traction through effective combination regimens and broader clinical use. Despite metastatic melanoma often being incurable, the emergence of advanced treatments such as immune checkpoint inhibitors and targeted therapies has markedly improved survival and quality of life, signaling a significant evolution in the standard of care.
Learn more about the melanoma treatment options @ Melanoma Treatment Guidelines
Melanoma Emerging Drugs and Companies
Some of the products in the pipeline include Lerapolturev (Istari Oncology), Nidlegy (Philogen), GIM-531 (Georgiamune), DOC-1021 (Diakonos Oncology), IMA203 (Immatics Biotechnologies), RP1 (vusolimogene oderparepvec) plus nivolumab (Replimune and BMS), APG-115 (Ascentage Pharma), Naporafenib (ERAS-254) (Erasca), KB707 (Krystal Biotech), Darovasertib (IDE196) (IDEAYA Biosciences and Novartis), HBI-8000 (HUYA Bioscience and BMS), Fianlimab (Regeneron Pharmaceuticals), and others.
IMA203 is a TCR T-cell therapy that targets the Preferentially Expressed Antigen in Melanoma (PRAME). It’s designed to identify an intracellular PRAME-derived peptide displayed on the surface of cells by HLA-A*02:01, triggering a strong and specific anti-tumor immune response. Encouraging Phase Ib results, along with PRAME’s high expression rate in melanoma (~90–95%), support IMA203’s therapeutic promise. The therapy is currently under investigation in the SUPRAME Phase III trial (NCT06743126) for previously treated advanced or metastatic cutaneous melanoma, and its Phase Ib expansion now includes uveal melanoma.
According to the company’s 2024 Annual Report, interim analysis for IMA203 is expected in Q1 2026, with final Phase III results in Q4 2026. A Biologics License Application (BLA) submission is planned for Q1 2027, aiming for a market launch in Q3 2027.
RP1 is a herpes simplex virus-based therapy modified with a fusogenic protein (GALV-GP R) and GM-CSF to enhance tumor cell destruction, increase immunogenic cell death, and promote a systemic anti-tumor immune response. The FDA has awarded Breakthrough Therapy Designation (BTD) for RP1 in combination with nivolumab for adults with advanced melanoma that has progressed after anti-PD1 treatment. In June 2025, Replimune shared updated results from the IGNYTE study (RP1 + nivolumab in anti-PD1-refractory melanoma) at the 2025 ASCO Annual Meeting.
Darovasertib (IDE196) is a potent, selective PKC inhibitor in clinical development. PKC lies downstream of the GNAQ and GNA11 pathways. Darovasertib is currently in a Phase III trial for primary non-metastatic uveal melanoma, a Phase II/III (DAR-UM-2) study for HLA-A2-negative metastatic uveal melanoma (MUM), and other Phase II trials in ocular melanoma. The company expects results from the pivotal DAR-UM-2 trial in first-line HLA-A2-negative MUM by late 2025. In March 2025, the FDA granted BTD to darovasertib for neoadjuvant treatment of primary uveal melanoma patients recommended for enucleation.
The anticipated launch of these emerging melanoma therapies are poised to transform the Melanoma market landscape in the coming years. As these cutting-edge melanoma therapies continue to mature and gain regulatory approval, they are expected to reshape the melanoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
To know more about new treatment for melanoma, visit @ Melanoma Management
The melanoma market dynamics are anticipated to change in the coming years. Drugs like OPDIVO and KEYTRUDA, particularly in combination with ipilimumab, have significantly improved overall survival and achieved durable response rates (~30–40%) in metastatic melanoma; however, the limited long-term efficacy in many patients highlights the urgent need for effective second-line therapies and continued innovation.
With nearly 50% of melanoma patients harboring BRAF mutations, targeted therapy has become a viable option, while molecular profiling enables patient stratification even in refractory settings for clinical trials and off-label interventions. Moreover, targeting underrepresented melanoma subtypes such as uveal, mucosal, and acral presents opportunities for market expansion and accelerated regulatory pathways, given the high unmet need and paucity of existing therapies.
Furthermore, many potential therapies are being investigated for the treatment of melanoma, and it is safe to predict that the treatment space will significantly impact the melanoma market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate is expected to drive the growth of the melanoma market in the 7MM.
However, several factors may impede the growth of the melanoma market.
Moreover, melanoma treatment poses a significant economic burden and disrupts patients’ overall well-being and QOL. Furthermore, the melanoma market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the melanoma market growth.
| Melanoma Report Metrics | Details |
| Study Period | 2020–2034 |
| Melanoma Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Key Melanoma Companies | Istari Oncology, Philogen, Georgiamune, Diakonos Oncology, Immatics Biotechnologies, Replimune, BMS, Ascentage Pharma, Erasca, Krystal Biotech, IDEAYA Biosciences, Novartis, HUYA Bioscience, Regeneron Pharmaceuticals, and others |
| Key Melanoma Therapies | Lerapolturev, Nidlegy, GIM-531, DOC-1021, IMA203, RP1 (vusolimogene oderparepvec) plus nivolumab, APG-115, Naporafenib (ERAS-254), KB707, Darovasertib (IDE196), HBI-8000, Fianlimab, and others |
Scope of the Melanoma Market Report
- Melanoma Therapeutic Assessment: Melanoma current marketed and emerging therapies
- Melanoma Market Dynamics: Conjoint Analysis of Emerging Melanoma Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, Melanoma Market Access and Reimbursement
Discover more about melanoma drugs in development @ Melanoma Clinical Trials
Table of Contents
| 1. | Melanoma Market Key Insights |
| 2. | Melanoma Market Report Introduction |
| 3. | Melanoma Market Overview at a Glance |
| 4. | Melanoma Market Executive Summary |
| 5. | Disease Background and Overview |
| 6. | Melanoma Treatment and Management |
| 7. | Melanoma Epidemiology and Patient Population |
| 8. | Patient Journey |
| 9. | Melanoma Marketed Drugs |
| 10. | Melanoma Emerging Drugs |
| 11. | Seven Major Melanoma Market Analysis |
| 12. | Melanoma Market Outlook |
| 13. | Potential of Current and Emerging Therapies |
| 14. | KOL Views |
| 15. | Unmet Needs |
| 16. | SWOT Analysis |
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